ID

20409

Beschrijving

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00724503

Link

https://clinicaltrials.gov/show/NCT00724503

Trefwoorden

  1. 21-02-17 21-02-17 -
Geüploaded op

21 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00724503

Eligibility Colorectal Cancer NCT00724503

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal and measurable ct evidence of liver metastases which are not treatable by surgical resection or local ablation.
Beschrijving

Liver metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0494165
limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).
Beschrijving

Extra-hepatic metastases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
suitable for either treatment regimen.
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
prior chemotherapy for metastatic colorectal cancer is not allowed.
Beschrijving

Prior chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
who performance status 0-1.
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
adequate hematological, renal and hepatic function.
Beschrijving

Hematological, renal and hepatic function

Datatype

boolean

Alias
UMLS CUI [1]
C0541533
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
age 18 years or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to provide written informed consent.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy of at least 3 months without any active treatment.
Beschrijving

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
previous radiotherapy delivered to the upper abdomen.
Beschrijving

Previous radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
Beschrijving

Non-malignant disease which interferes with study protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513063
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
peripheral neuropathy > grade 1 (nci-ctc).
Beschrijving

Peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0031117
dose limiting toxicity with previous adjuvant 5-fu or oxaliplatin chemotherapy.
Beschrijving

Dose limiting toxicity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512043
UMLS CUI [1,2]
C0013221
prior non-adjuvant chemotherapy for any malignancy. adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
Beschrijving

Prior non-adjuvant chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C1518422
pregnant or breast-feeding.
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other active malignancy.
Beschrijving

Malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Colorectal Cancer NCT00724503

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver metastases
Item
unequivocal and measurable ct evidence of liver metastases which are not treatable by surgical resection or local ablation.
boolean
C0494165 (UMLS CUI [1])
Extra-hepatic metastases
Item
limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Organ function
Item
suitable for either treatment regimen.
boolean
C0678852 (UMLS CUI [1])
Prior chemotherapy
Item
prior chemotherapy for metastatic colorectal cancer is not allowed.
boolean
C1514457 (UMLS CUI [1])
Performance status
Item
who performance status 0-1.
boolean
C1518965 (UMLS CUI [1])
Hematological, renal and hepatic function
Item
adequate hematological, renal and hepatic function.
boolean
C0541533 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Life expectancy
Item
life expectancy of at least 3 months without any active treatment.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity
Item
evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
boolean
C0009488 (UMLS CUI [1])
Previous radiotherapy
Item
previous radiotherapy delivered to the upper abdomen.
boolean
C1522449 (UMLS CUI [1])
Non-malignant disease which interferes with study protocol
Item
non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
boolean
C1513063 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Peripheral neuropathy
Item
peripheral neuropathy > grade 1 (nci-ctc).
boolean
C0031117 (UMLS CUI [1])
Dose limiting toxicity
Item
dose limiting toxicity with previous adjuvant 5-fu or oxaliplatin chemotherapy.
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Prior non-adjuvant chemotherapy
Item
prior non-adjuvant chemotherapy for any malignancy. adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
boolean
C1514457 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Gynaecological status
Item
pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignancy
Item
other active malignancy.
boolean
C0006826 (UMLS CUI [1])

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